Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to investigate the pharmacokinetics, safety and tolerability of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (FDC) to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Santen Oy
• Treatments: Ophthalmic Solutions; Tetrahydrozoline; Timolol

Criteria

Inclusion Criteria:

• Aged 18 to 45 years

• Good general health

• Meet best corrected ETDRS visual acuity

Exclusion Criteria:

• Significant systemic or ocular disease

• History of eye surgery, including refractive surgery

• Allergy or hypersensitivity to study drug

• Low heart rate (<50 bpm)

• Clinically relevant low blood pressure

• Asthma

• Bradycardia

• Use of contact lenses within one week prior to screening or during the study

• Clinically significant obesity (body mass index > 30 kg/m2)

• Blood donation within 2 months prior to screening

• Females who are pregnant or lactating and females not using adequate contraceptives